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Randomized Controlled Trial
. 2021 Sep 7;73(5):824-831.
doi: 10.1093/cid/ciab153.

Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial

Julia C Dombrowski  1   2 , Michael R Wierzbicki  3 , Lori M Newman  4 , Jonathan A Powell  3 , Ashley Miller  5 , Dwyn Dithmer  2 , Olusegun O Soge  6 , Kenneth H Mayer  7   8
Affiliations
Randomized Controlled Trial

Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial

Julia C Dombrowski et al. Clin Infect Dis. .

Abstract

Background: Azithromycin and doxycycline are both recommended treatments for rectal Chlamydia trachomatis (CT) infection, but observational studies suggest that doxycycline may be more effective.

Methods: This randomized, double-blind, placebo-controlled trial compared azithromycin (single 1-g dose) versus doxycycline (100 mg twice daily for 7 days) for the treatment of rectal CT in men who have sex with men (MSM) in Seattle and Boston. Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent repeated collection of rectal swabs for nucleic acid amplification testing (NAAT) at study enrollment and 2 weeks and 4 weeks postenrollment. The primary outcome was microbiologic cure (CT-negative NAAT) at 4 weeks. The complete case (CC) population included participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants.

Results: Among 177 participants enrolled, 135 (76%) met CC population criteria for the 4-week follow-up visit. Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative. Microbiologic cure was higher with doxycycline than azithromycin in both the CC population (100% [70 of 70] vs 74% [48 of 65]; absolute difference, 26%; 95% confidence interval [CI], 16-36%; P < .001) and the ITT population (91% [80 of 88] vs 71% [63 of 89]; absolute difference, 20%; 95% CI, 9-31%; P < .001).

Conclusions: A 1-week course of doxycycline was significantly more effective than a single dose of azithromycin for the treatment of rectal CT in MSM.

Clinical trials registration: NCT03608774.

Keywords: Chlamydia trachomatis; rectal infection; sexual and gender minorities; sexually transmitted diseases; therapeutics.

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Figures

Figure 1.
Figure 1.
Study flow chart. Abbreviations: CC, complete case; CT, Chlamydia trachomatis; ITT, intention-to-treat; NAAT, nucleic acid amplification testing; PP, per protocol.
Figure 2.
Figure 2.
 Comparison of 2-week and 4-week cure percentage by treatment group and analysis population.
See this image and copyright information in PMC

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References

    1. Centers for Disease Control and Prevention. Sexually transmitted disease surveillance 2018. 2019. Available at: https://www.cdc.gov/std/stats18/default.htm. Accessed 21 September 2020.
    1. Johnson Jones ML, Chapin-Bardales J, Bizune D, et al. Extragenital chlamydia and gonorrhea among community venue-attending men who have sex with men—five cities, United States, 2017. MMWR Morb Mortal Wkly Rep 2019; 68:321–325. - PMC - PubMed
    1. Patel MR, Brooks JT, Tie Y, Garg S, Bradley H. Prevalence of gonorrhea and chlamydia testing by anatomical site among men who have sex with men in HIV Medical care, United States, 2013–2014. Sex Transm Dis 2017; 45:25–27. - PMC - PubMed
    1. Chambers LC, Morgan JL, Lowens MS, et al. Cross-sectional study of urethral exposures at last sexual episode associated with non-gonococcal urethritis among STD clinic patients. Sex Transm Infect 2019; 95:212–8. - PMC - PubMed
    1. Barbee LA, Khosropour CM, Dombrowksi JC, Golden MR. New human immunodeficiency virus diagnosis independently associated with rectal gonorrhea and chlamydia in men who have sex with men. Sex Transm Dis 2017; 44:385–9. - PMC - PubMed

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